Members of Congress Join Laboratory Developed Test Controversy by Ken_Powell
Nine Democratic Representatives are urging the Obama Administration to release the FDA’s draft guidance on the regulation of Laboratory Developed Tests (LDTs).
A letter sent to Sylvia Mathews Burwell, the Director of the Office of Management and Budget said that the development and widespread use of advanced diagnostics require that the FDA move its guidance forward to “ensure the appropriate and efficient oversight of safe and effective diagnostics”. The legislators further wrote that the lack of FDA oversight “could put patients at safety risks without the FDA’s assurance that the tests (LDTs) are effective.
Molecular diagnostics is one of the fastest growing segments of the $52 billion dollar global In Vitro Diagnostics (IVD) industry. While many molecular diagnostic tests have been approved by the FDA, there are an estimated 3,000 LDTs that have not. A national registry of LDTs does not exist at the present time. Should the FDA decide to move forward and “set its sights on regulating LDTs” as stated by FDA Commissioner Margret Hamburg last June, several major IVD players could be impacted.
For more information on LDTs, issues and potential impact please contact me through Zintro and schedule an individual discussion.